Regulatory Affairs Manager Position Overview
The Regulatory Affairs Manager is responsible for leading the EMEA Regulatory Affairs executing function. This role involves developing and executing regional regulatory strategies, overseeing Economic Operator responsibilities under EU MDR, and managing product registrations and notifications across applicable markets.
This position ensures regulatory compliance, drives cross-functional collaboration, and supports business objectives. The RA Manager also plays a key role in mentoring and developing team members, managing performance, and fostering a culture of continuous improvement and regulatory excellence.
* Main Responsibilities:
* Provide strategic leadership and oversight for the International Regulatory Affairs team across the EMEA region.
* Serve as the designated delegate for the Person Responsible for Regulatory Compliance (PRRC).
* Ensure that all products, processes, and documentation comply with relevant global regulatory requirements, standards, and internal quality systems.
* Develop, implement, and continuously refine regulatory strategies for new and existing products to support timely market access and business growth.
* Lead talent development initiatives within the Regulatory Affairs team.
* Foster strong collaboration with Business Unit (BU) and regional stakeholders.
* Provide regulatory oversight for product and process changes.
* Approve and/or oversee the preparation of regulatory submissions.
* Monitor evolving regulatory requirements.
* Collaborate with global regulatory counterparts and technical experts.
* Act as a regulatory point of contact for internal departments and external stakeholders.
* Lead and support regulatory inspections and audits.
* Manage regulatory projects.
Education and Experience Requirements
* Minimum 5 – 7 years experience in a similar role and medical device background
* Degree in Regulatory, Biomedical Engineering or Science related discipline
* Strong understanding of relevant regulations and guidelines
* Key Skills and Qualifications
* Excellent verbal and written communication skills
* Ability to manage multiple projects and deadlines effectively
* Ability to analyze regulations and assess their impact
* Meticulous in preparing and reviewing documentation
* Ability to identify and resolve compliance issues
* Ability to guide and motivate a team
Specialized Skills / Other Requirements
* Key Relationships/Interfaces
* VP of RAQA
* VP of RA
* Director RA, EMEA
* Global RA / Product Management RA
* Customer Service
* EMEA Commercial Teams
Behaviours/Values:
* Approachable and enthusiastic
* Flexible and adaptable
* Good organizational skills with cultural awareness and sensitivity
* Good judgment and problem-solving ability
* Strong collaboration and influencing skills
* Excellent communication skills
* Goal orientated for customer and business objectives
* Coeffing/Mentoring skills
Work Environment
This role will require approximately 20% travel.